The TP Regimen in the Treatment of Early Triple Negative Breast Cancer

• Status: Recruiting
• Trial end date: 2022-11-23
• Target enrollment: 0
• Participant gender: Female

Summary

Previous studies have shown that TNBC is sensitive to DNA crosslinking-related chemotherapeutic drugs such as platinum. However, there is a lack of large sample prospective clinical data to compare the efficacy of TP and EC-T / TEC regimen in the neoadjuvant chemotherapy of TNBC. Besides, the application of anthracycline drugs is limited to a certain extent due to the cardiotoxicity. Based on the above evidence, the researchers hope to explore a more effective and safer new adjuvant therapy for TNBC.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henan Cancer Hospital
• Treatments: Cyclophosphamide; Docetaxel; Doxorubicin

Criteria

Inclusion Criteria:

1. Age: 18-70.

2. Clinical T2-T4c, or T1c with axillary LN+.

3. triple negative and invasive breast cancer confirmed by histopathology:

Triple negative breast cancer is defined as:

• negative for ER and PR (IHC nuclear staining < 1%).

• Her-2 negative (IHC 0,1 + without FISH, or IHC 2 + and FISH without amplification).

4. Clinically evaluable lesions: The presence of lesions that could be evaluated by ultrasound, molybdenum target or magnetic resonance imaging (optional) was within 1 month before randomization.

5. The function examination of organs/bone marrow showed no contraindication within 1 month before chemotherapy.

• The absolute value of neutrophil count ≥2.0 × 109 / L.

• The value of hemoglobin ≥100g/L.

• Platelet count ≥100 × 109/L.

• Total bilirubin < 1.5 ULN (normal value online).

• Creatinine < 1.5 × ULN.

• AST/ALT < 1.5 × ULN.

6. The EF value of echocardiography≥55%.

7. The serum pregnancy test was negative for fertile woman within 14 days before randomization..

8. KPS score≥80.

9. Informed consent.

Exclusion Criteria:

1. Metastatic breast cancer.

2. Before entering the clinical trial, patients had received chemotherapy, endocrine therapy, targeted therapy, radiotherapy and so on.

3. The patient had dual primary malignancies, except for skin cancer, which was treated.

4. Combined with other serious and uncontrollable medical diseases, the researchers judged that the disease had chemotherapy contraindications.